Taiwan Cosmetic Law Clarifications

TFDA shares its views on how the prospective new statute will be implemented.

For the past several years, the Taiwan government has been working on revisions to the Statute for Control of Cosmetics Hygiene (the Cosmetics Act for short) to bring it up to date with current market approaches to protecting consumer interests. With the executive-branch draft of the legislation now submitted to the Legislative Yuan for approval, industry has turned its attention to the enforcement regulations to be adopted by the Taiwan Food and Drug Administration (TFDA) once the law is passed.

As set out in the past few editions of AmCham Taipei’s annual Taiwan White Paper, industry has cautioned that the regulatory stance needs to be carefully considered so as not to discourage innovation, pose any technical barriers to trade, or depart substantially from international best practices.

Last month, the Commercial Section of the American Institute in Taiwan played host to TFDA representatives and regulatory-affairs specialists from cosmetic-company members of AmCham’s Retail Committee, providing an opportunity for discussion of industry’s concerns as to how the new law will be implemented. “Our members found it to be an extremely positive meeting,” says Chamber president Andrea Wu. “Most of the issues they were concerned about have now been clarified to a large extent, and on others there will be opportunity for further input down the line.”

Examples of issues covered include:

Product registration and notification. The draft Act calls for phasing out the current pre-market registration system and replacing it with a new system of post-market notification. Industry was concerned that during the five-year transition period, specific-purpose cosmetics (those containing medicated ingredients) would face a double burden of having to comply simultaneously with both systems. At the meeting, TFDA gave assurances that only registration, not notification, would be required during the transition.

Product Information Files (PIF). The new post-market system will require the submission of PIFs under certain circumstances. TFDA eased companies’ concerns by pledging to consult industry when setting PIF requirements, to align those requirements with global standards, and to accept either electronic files or hard-copy versions. It also said the amount of time needed by a company to prepare a PIF upon request would be taken into account.

Ingredient restrictions. Industry has stressed that when the new law is enforced, limits or restrictions on ingredients must be based on scientific evidence and harmonized with the regulations of Taiwan’s trade partners. These restricted items include such ingredients as preservatives, colorants, UV filters, and hair dyes. TFDA officials acknowledged industry’s concerns and said they would consider the comments when setting new standards.

The Taiwan Cosmetic GMP standard. Industry was concerned that the new law would require all suppliers, including overseas suppliers, to comply with the Taiwan Cosmetic GMP (Good Manufacturing Practice) standard announced by the Taiwan government, with compliance to be judged by Taiwan officials. As most U.S. suppliers are unfamiliar with the Taiwan Cosmetic GMP, requiring it as the standard could constitute a trade barrier blocking certain imports. TFDA explained that executive orders to be issued after enactment of the new law will make clear that any globally recognized GMP or ISO22716 will be accepted as equivalent to the Taiwan Cosmetic GMP standard.

Enforcement powers. Article 15 of the draft law would allow TFDA to order a halt to the sale or import of products on suspicion that the expiry date has passed, that the goods are of unknown origin, or that there may be an adverse effect on human health. If no violation is found, TFDA would then permit the resumption of sales. Industry has expressed concern that the power granted to TFDA is too broad, calling it unreasonable for sales to be halted based only on suspicions, before any investigation has been conducted. TFDA agreed to consider industry’s suggestions for how the enforcement rules for that article should be worded to resolve the problem.

Treatment of misleading advertising. TFDA said it will adopt well-thought-out measures to regulate misleading ads. Only in the most “serious situations” – described as involving repeat offenders who have advertised their products with exaggerated or false claims that caused a severe threat to human safety – would TFDA consider taking the extreme step of demanding that the supplier publish corrective advertisements or statements. TFDA further responded to industry’s concerns by saying that the term “serious situations” would be clearly defined in the enforcement rules or by executive order.

Regulation of toothpaste and mouthwash. The new law would classify toothpaste and mouthwash for the first time as coming under cosmetics regulations. Given the very different regulatory standards to be applied, manufacturers are asking for a grace period of at least five years to prepare for the change. They also request that the authorities, in setting the list of permissible ingredients, accept all substances allowed by such major trading partners as the United States, EU, or Japan. Finally, they hope that current allowable advertising claims for toothpaste continue to be applied after reclassification. In response, TFDA agreed to provide a reasonable grace period for the transition, invited industry to provide further suggestions for setting ingredient standards, and confirmed that the current allowable advertising claims will continue to be in place.

“AmCham is grateful to AIT for arranging this meeting, and very much appreciates TFDA’s forthcoming attitude in listening to industry’s concerns,” says Andrea Wu. “Regarding the several points still to be resolved as the enforcement rules are drafted, our members will certainly take up TFDA’s invitation to provide their further suggestions.”

Don Shapiro is Editor-in-Chief of Taiwan Business TOPICS and Senior Director of the AmCham Taipei. Before joining the AmCham staff in 2002, he was president of the Trade Winds publishing company and Taiwan correspondent for Time Inc.

Taiwan Business TOPICS

Taiwan Business TOPICS is published monthly by the American Chamber of Commerce in Taipei, and covers current topic affecting business conditions in Taiwan, an Industry Focus section on a particular industrial sector, and other reports prepared by the magazine’s staff of experienced professional journalists.